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Lasofoxifene · 1 trial · 1 indication
PFS is defined as the time from the date of randomization \[Visit 0 (Day 1)\] to the earliest date of first documented progression per RECIST 1.1 as determined by BICR or death due to any cause.
| Arm | Type | Description |
|---|---|---|
| Treatment | EXPERIMENTAL | Pre- and Postmenopausal Women and Men with locally advanced or metastatic ER+/HER2- breast cancer who have disease progression on an AI in combination with either palbociclib or ribociclib as their first hormonal treatment for metastatic disease and who have an ESR1 mutation. |
| Reference Therapy | ACTIVE_COMPARATOR | Pre- and Postmenopausal Women and Men with locally advanced or metastatic ER+/HER2- breast cancer who have disease progression on an AI in combination with either palbociclib or ribociclib as their first hormonal treatment for metastatic disease and who have an ESR1 mutation. |
| Name | Type | Description |
|---|---|---|
| Lasofoxifene in combination with abemaciclib | DRUG | 5 mg/d of oral lasofoxifene plus oral abemaciclib 150 mg twice a day |
| Fulvestrant in combination with abemaciclib | DRUG | Fulvestrant 500 mg intramuscular (IM) on Days 1, 15, and 29 and then once monthly thereafter plus oral abemaciclib 150 mg twice a day |
Inclusion Criteria: 1. Pre- or postmenopausal women or men. 2. Locally advanced and/or metastatic ER+ breast cancer with radiological or clinical evidence of progression on an AI in combination with either palbociclib or ribociclib as their first hormonal treatment for metastatic disease. 3. Histol...
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Lasofoxifene is being studied in combination with abemaciclib for locally advanced or metastatic ER+/HER2- breast cancer that carries an ESR1 mutation. It is an investigational therapy in Phase 3 development and is not approved for this use. The trial enrolls adults with tumors that progressed on prior endocrine therapy.
Lasofoxifene targets the estrogen receptor, or ER. It is a small molecule designed to bind and modulate ER activity in ER-positive breast cancer cells. The Phase 3 study specifically enrolls patients whose tumors have an ESR1 mutation, a change that can arise after prior endocrine treatment.
Lasofoxifene is being developed by LeonaBio, Inc., which trades under the ticker LONA. The company is running the Phase 3 program in metastatic breast cancer. The lead study combines lasofoxifene with abemaciclib and compares it with fulvestrant plus abemaciclib.
Lasofoxifene is in Phase 3 clinical development for metastatic breast cancer. It is investigational and has not been approved by the FDA for this indication. The ongoing Phase 3 trial is randomized, active-controlled, and biomarker-selected for patients with an ESR1 mutation.
Lasofoxifene is being evaluated in the Phase 3 trial NCT05696626, titled Evaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation. The study is recruiting and plans to enroll 600 participants across sites in the United States, Europe, Asia, and Australia.